Manufacturers, Annual Reports

FDA’s Center for Drug Evaluation and Research (CDER) Issues FY2023 Annual Report

Gardner Law on 2/23/2024

In January 2024, the Office of Compliance at the FDA’s Center for Drug Evaluation Research (CDER) released its Annual Report for FY2023. The Annual Report contains several useful pieces of information for drug companies and...more

SEC Proposed Rule on Climate-Related Disclosures: A Look at Scope 3 Emissions Reporting Requirements

Robinson+Cole Manufacturing Law Blog on 3/28/2022

True to its word, the SEC released its proposed rule, The Enhancement and Standardization of Climate-Related Disclosures for Investors, last week. The rule would require companies to disclose a wide variety of climate-related...more

FDA to Develop National Standards for Drug Distributors – Medical Products Supply Chain Week in Review

Alston & Bird on 3/15/2022

Since our last update, the Senate confirmed Dr. Robert Califf as commissioner of the U.S. Food and Drug Administration. The FDA resumed domestic and foreign inspections. The agency also published a proposed rule to update...more

FDA proposes annual summary reporting requirements for Right to Try drug sponsors, manufacturers

Hogan Lovells on 7/27/2020

On July 23, the U.S. Food and Drug Administration (FDA) announced a new proposed rule that would require sponsors and manufacturers who provide an ‘‘eligible investigational drug’’ under the Right to Try Act to submit an...more

Assessing Slavery and Human Trafficking Risks

BCLP on 1/30/2020

The Modern Slavery Act (“MSA”) was introduced in the United Kingdom in October 2015 introducing criminal offences of slavery, servitude, forced or compulsory labour and human trafficking. However, its most profound impact has...more

Stout Issues Third Annual Warranty and Recall Report

Foley & Lardner LLP on 9/21/2017

Massive automotive recalls continue to grab headlines and raise concerns industry-wide. Recalls of light vehicles topped 50 million units in 2016, representing the third consecutive year of elevated – and record setting –...more

Blog: CMS’ Annual Open Payments Report to Congress Highlights Some Key Areas to Watch

Cooley LLP on 5/6/2015

The Centers for Medicare & Medicaid Services (CMS) must submit an annual report to Congress in connection with the federal Sunshine law. ...more

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